Monday, July 27, 2015

Safe for babies?

The
world's first malaria vaccine got a green light on Friday from European drugs
regulators who recommended it as safe and effective to use in babies in Africa
at risk of the mosquito-borne and lifer-threatening disease.

The shot, called Mosquirix and developed by British drug maker
GlaxoSmithKline and the PATH Malaria Vaccine Initiative, would be the first
licensed human vaccine against a parasitic disease and could help to prevent
millions of cases of the killer disease in countries that use it, Reuters
reported.

Mosquirix, whose scientific name is "RTS,S" has been
designed to prevent malaria caused by the Plasmodium falciparum parasite, which
is most prevalent in sub-Saharan Africa. It is the first vaccine to be
developed which counters the effects of a parasite.

According to the WHO, 627,000 deaths from malaria were reported
globally in 2013, of which the vast majority (562,000) occurred in Africa,
mostly among children under the age of five years (82%).

Mosquirix, which is part-funded by the Bill and Melinda Gates
Foundation, will now be assessed by the World Health Organisation (WHO), which
said on Friday it would begin a review in October on when and where it could be
used. The WHO aims to make a recommendation by November.

"We will look at the vaccine from the point of view of public
health," WHO spokesman Gregory Hartl was quoted by Reuters as saying.
"We need to think closely about how best to add - and if to add - a
malaria vaccine across certain malaria endemic areas."

Andrew Witty, GSK's chief executive, said the European Medicines
Agency's (EMA) positive opinion was an important step towards making the
world's first malaria vaccine available.

"While RTS,S on its own is not the complete answer to
malaria, its use alongside those interventions ... such as bed nets and
insecticides would provide a very meaningful contribution to controlling the
impact of malaria on children in those African communities that need it the
most," he said.

Mosquirix was assessed for quality, safety and efficacy under a
special procedure that allows the EMA to evaluate a product even if it will not
be marketed in the European Union.

Beyond the WHO's November recommendation, Mosquirix would still
have to be reviewed by national regulatory authorities in any country wishing
to use it. The WHO's Hartl said this meant it is unlikely to be rolled out
anywhere until at least 2017. –End-